Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 12:45 AM
Study NCT ID:
NCT04383860
Status:
COMPLETED
Last Update Posted:
2021-06-15
First Post:
2020-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sutures in Orbital Implants in Retinoblastoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012175', 'term': 'Retinoblastoma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D019572', 'term': 'Retinal Neoplasms'}, {'id': 'D005134', 'term': 'Eye Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-14', 'studyFirstSubmitDate': '2020-05-07', 'studyFirstSubmitQcDate': '2020-05-07', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of participants with complications', 'timeFrame': '2 year after surgery', 'description': 'complications, such as orbital implant exposure in the follow-up visit'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinoblastoma', 'suture', 'complications'], 'conditions': ['Surgery--Complications', 'Retinoblastoma Bilateral']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate different sutures for orbital implants in retinoblastoma patients.', 'detailedDescription': 'To evaluate the effectiveness and complications of 4-0 and 5-0 sutures for orbital implants in retinoblastoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed as retinoblastoma\n* enucleation and orbital implantation in the same surgery\n\nExclusion Criteria:\n\n* death during follow-up'}, 'identificationModule': {'nctId': 'NCT04383860', 'briefTitle': 'Sutures in Orbital Implants in Retinoblastoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Choice of Sutures in Orbital Implants in Retinoblastoma Patients', 'orgStudyIdInfo': {'id': '202001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5-0 suture', 'description': '5-0 suture administration during surgery', 'interventionNames': ['Procedure: 5-0 suture']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4-0 suture', 'description': '4-0 suture administration during surgery', 'interventionNames': ['Procedure: 4-0 suture']}], 'interventions': [{'name': '5-0 suture', 'type': 'PROCEDURE', 'otherNames': ['5-0 suture administration'], 'description': '5-0 suture administration during surgery', 'armGroupLabels': ['5-0 suture']}, {'name': '4-0 suture', 'type': 'PROCEDURE', 'otherNames': ['4-0 suture administration'], 'description': '4-0 suture administration during surgery', 'armGroupLabels': ['4-0 suture']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Huijing Ye', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Huijing Ye', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}